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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004819-40 | EudraCT Number | ||
| 28431754DIA4004 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin.
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a study drug, to test whether the study drug has a real effect), multicenter study of efficacy, safety, and tolerability of canagliflozin in participants with T2DM, who have inadequate glycemic (blood sugar) control on maximally or near-maximally effective doses of metformin >=1500 mg/day and sitagliptin 100 mg/day. Approximately 200 participants will be randomly assigned to 1 of 2 treatment groups in 1:1 ratio for 26 weeks. During the study the participants will be also provided with diet and exercise counseling (standardized non-pharmacological therapy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canagliflozin (JNJ-28431754) | Experimental | Each participant will receive canagliflozin (JNJ-28431754) 100 mg once daily during the first 6 weeks, then the dose may be increased to 300 mg once daily. |
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| Placebo | Placebo Comparator | Each participant will receive placebo (inactive medication) once daily for 28 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin, 100 mg | Drug | One 100 mg capsule taken orally (by mouth) once daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 | Baseline and Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 | Baseline and Week 26 | |
| Percent Change From Baseline in Body Weight at Week 26 | Baseline and Week 26 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montgomery | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29313267 | Derived | Cai J, Delahanty LM, Akapame S, Slee A, Traina S. Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials. Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4. |
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One participant was randomized at 2 different sites (once to placebo and once to canagliflozin) and was therefore counted twice in the total number of randomized participants. The participant was withdrawn from the study and not included in any efficacy or safety analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants administered with placebo (inactive medication) once daily for 26 weeks. |
| FG001 | Canagliflozin | Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Canagliflozin, 300 mg | Drug | One 300 mg capsule taken orally (by mouth) once daily. |
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| Placebo | Drug | One placebo capsule taken orally (by mouth) once daily. |
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| Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26 |
| Week 26 |
| Change From Baseline in Systolic Blood Pressure (SBP) at Week 26 | Baseline and Week 26 |
| Phoenix |
| Arizona |
| United States |
| Little Rock | Arkansas | United States |
| Northridge | California | United States |
| Norwalk | California | United States |
| Rancho Cucamonga | California | United States |
| San Ramon | California | United States |
| Aurora | Colorado | United States |
| Denver | Colorado | United States |
| Littleton | Colorado | United States |
| Cooper City | Florida | United States |
| Miami | Florida | United States |
| North Miami Beach | Florida | United States |
| Atlanta | Georgia | United States |
| Perry | Georgia | United States |
| Shawnee Mission | Kansas | United States |
| Marrero | Louisiana | United States |
| Metairie | Louisiana | United States |
| Metarie | Louisiana | United States |
| Rockville | Maryland | United States |
| Jackson | Mississippi | United States |
| Picayune | Mississippi | United States |
| St Louis | Missouri | United States |
| Nashua | New Hampshire | United States |
| Albuquerque | New Mexico | United States |
| Albany | New York | United States |
| Arlington | Texas | United States |
| San Antonio | Texas | United States |
| Sugarland | Texas | United States |
| Bountiful | Utah | United States |
| Coffs Harbour | Australia |
| Freemantle | Australia |
| Geelong | Australia |
| Heidelberg | Australia |
| Herston | Australia |
| Melbourne | Australia |
| Merewether | Australia |
| Sherwood | Australia |
| Sydney | Australia |
| Wollongong | Australia |
| Brampton | Ontario | Canada |
| Hawkesbury | Ontario | Canada |
| Toronto | Ontario | Canada |
| La Rochelle Cedex 1 Poitou-Cha | France |
| La Tronche | France |
| Nancy | France |
| Narbonne | France |
| Nice | France |
| Paris | France |
| Vénissieux | France |
| Freiburg im Breisgau | Germany |
| Fulda | Germany |
| Hamburg | Germany |
| Münster | Germany |
| Neuwied | Germany |
| Pirna | Germany |
| Speyer | Germany |
| COMPLETED |
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| NOT COMPLETED |
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mITT (modified intent-to-treat) population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants administered with placebo (inactive medication) once daily for 26 weeks. |
| BG001 | Canagliflozin | Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 | mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | percentage of glycosylated hemoglobin | Baseline and Week 26 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 | mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | millimoles per liter | Baseline and Week 26 |
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| Secondary | Percent Change From Baseline in Body Weight at Week 26 | mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and Week 26 |
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| Secondary | Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26 | mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) at Week 26 | mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | millimeter of mercury (mmHg) | Baseline and Week 26 |
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From Baseline, up to end of treatment (Approximately 31 weeks)
Safety population included all randomized participants who received at least 1 dose of double-blind study drug and 3 participants who were excluded from the mITT population due to potential misconduct and GCP compliance issues.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants administered with placebo (inactive medication) once daily for 26 weeks. | 2 | 108 | 16 | 108 | ||
| EG001 | Canagliflozin | Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks. | 2 | 108 | 18 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Unstable | Cardiac disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Cerebral Infarction | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Transient Ischaemic Attack | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Polyuria | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Clinical Leader | Janssen Research & Development, LLC | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| Male |
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| Canada |
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| France |
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| Germany |
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| United States |
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